Do data from a large prospective naturalistic study (N=1014, MDD) support the new FDA recommendation concerning antidepressants suicidality risk?

Background: In 2007, FDA released new data and emphasized the increased risk of suicidality in young adults being treated with antidepressants. We aimed at analysing the data of a naturalistic prospective multicenter study for risk factors for emergence of suicidal ideation and suicide attempts. Methods: Data from 10 centres in Germany (N=1073) were analysed. All patients were hospitalised and had to meet DSM–IV criteria for MDD. For statistical analyses, two events, emergence of suicidal ideation and suicide attempts were defined. Emergence of suicidal ideation was defined according to corresponding suicidality items MADRS 10 (increase from 0 or 1 to >4), HAMD-21 item 3 (increase from 0 or 1 to 2 or 4) and BDI-I (increase from 1 to >3). Results: Baseline mean total score on the HAMD-21 was 24.8. A significant effect of clinical treatment was evident by week 1 via decrease of HAMD, MDRS and BDI total scores (LOCF). There were 2 deaths due to suicide. The rate of suicide attempts (1.87%) was low and comparable to the rate in RCTs. Suicidality (suicide attempts and emergence) was significantly more frequent in patients being less than 45 years old. Conclusion: Being in inpatient treatment according to good clinical practice appears beneficial. Suicidality emerged more frequently in patients less than 45 years. This in line with epidemiological data and to a certain degree with the actual FDA recommendation.